US9138314B2

US9138314B2 - Prosthetic vascular conduit and assembly method

Info

Publication number: US9138314B2
Application number: US14/176,533
Authority: US
Inventors: Giovanni Rolando; Paolo Gaschino; Monica Achiluzzi; Felice Giuseppe Carlino
Original assignee: Sorin Group Italia SRL
Current assignee: Corcym SRL
Priority date: 2011-12-29
Filing date: 2014-02-10
Publication date: 2015-09-22
Also published as: EP2609893A1; US20140188217A1; US8685084B2; US20130172991A1; ES2523223T3; EP2842517A1; WO2013098739A1; EP2609893B1

Abstract

A kit for implanting a prosthetic vascular conduit includes a prosthetic vascular conduit for coupling to a prosthetic valve having an annular portion. The conduit includes a terminal collar member for receiving the valve. The kit further includes a holder including a shaft and a hub including a receiving portion configured for housing a prosthetic valve. The conduit is fitted on the holder so that at least a portion of the conduit wraps over the receiving portion of the hub. A sleeve member fitted onto the conduit in a position corresponding to the receiving portion of the hub, and a portion of the collar member is wrapped or folded over the sleeve member. The sleeve member is slidable away from the hub to unwrap the collar member such that it is disposed around the annular portion of a prosthetic valve.

Description

CROSS-REFERENCE TO RELATED APPLICATION

This application is a division of U.S. application Ser. No. 13/729,636, filed Dec. 28, 2012, now U.S. Pat. No. 8,685,084, which claims priority under §119 to European patent application EP 11425310.7, filed on Dec. 29, 2011, the content of which are incorporated herein by reference in their entirety.

TECHNICAL FIELD

The present disclosure relates to prosthetic vascular conduits or grafts and kits for the implantation thereof. Various embodiments may relate to kits for implanting prosthetic vascular conduits adapted to couple with an associated valve for controlling blood flow through the conduit.

BACKGROUND

Valved conduits or grafts, which are arrangements including a prosthetic vascular conduit with an associated prosthetic valve to control flow of blood through the conduit, may be used for various purposes including, for example, the replacement of the aortic valve in conjunction with the ascending aorta. The aorta is the largest blood vessel in the human body, carrying blood from the left ventricle of the heart throughout the body. The ascending aorta is the first section of the aorta, which stems from the left ventricle and extends to the aortic arch. The aortic valve is located at the root of the ascending aorta and controls the blood flow by permitting blood to flow from the left ventricle into the ascending aorta while preventing or restricting blood flow in the opposite direction. The coronary arteries, which supply blood to the heart muscle itself, branch from the ascending aorta. Downstream of the aortic valve, the wall of the ascending aorta exhibits three outward protrusions approximately spaced 120 degrees apart. These protrusions are known as the Valsalva sinuses. For replacement of the aortic valve and the ascending aorta, the valve in the valved conduit is arranged at one end of the prosthetic vascular conduit with its leaflets oriented to permit blood flow from the left ventricle into the conduit, while preventing blood flow out of the conduit in the opposite direction.

Practitioners may prefer having the option of coupling the valve to the conduit just before the replacement procedure. In some cases, for example, practitioners wish to couple the valve to the conduit, possibly in the operating room, only after the specific requirements (e.g., anatomy and pathology) of the patient are known. The coupling of the valve to the conduit and the subsequent implantation of the assembly may be important steps in any vascular surgery intervention. Practitioners are striving for reducing the overall time required for implanting a vascular prosthesis such as a prosthetic conduit, as saving time reduces the risk for the patient.

SUMMARY

Exemplary embodiments herein refer to a kit for the implantation of a prosthetic vascular conduit including:

- a prosthetic vascular conduit for coupling to a prosthetic valve having an annular portion, the prosthetic vascular conduit including a terminal collar member configured for receiving the annular portion of the valve, wherein the terminal collar member includes a cuff which is radially contractible to engage the annular portion of the valve to couple the valve to the conduit,
- a holder device including a shaft and a hub located at an end of a proximal portion of the shaft, the hub including a receiving portion configured for housing a prosthetic valve, wherein the prosthetic vascular conduit is fitted on the holder device so that at least a portion of the conduit adjacent to the cuff wraps the receiving portion of the hub,
- a sleeve member fitted onto the conduit in a position corresponding to the receiving portion of the hub, wherein the cuff is wrapped on the sleeve member, and wherein the sleeve member is slidable away from the hub to unwrap the cuff around the annular portion of a prosthetic valve housed within the receiving portion of the hub.

Exemplary embodiments herein may relate to a method of making a prosthetic valved conduit, the method including:

- providing a kit according to exemplary embodiments of the invention;
- providing a prosthetic heart valve having an annular portion;
- advancing the heart valve prosthesis into the receiving portion of the hub until the annular portion of the prosthetic heart valve contacts the receiving portion;
- sliding the sleeve member away from the hub to unwrap the cuff of the prosthetic vascular conduit around the annular portion of the prosthetic heart valve, and
- wrapping the cuff of the prosthetic vascular conduit over the annular portion of the prosthetic heart valve by providing a radial contraction of the cuff.

While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is an exemplary view of a kit including a prosthetic vascular conduit and a holder device as described herein.

FIG. 2 is a perspective view of the holder device of the kit shown in FIG. 1, without the prosthetic vascular conduit mounted thereon.

FIGS. 3 to 8 are exemplary of a sequence of coupling a prosthetic valve with the prosthetic vascular conduit and implanting the prosthetic vascular conduit and the heart valve at an implantation site as described herein, wherein FIGS. 5A, 6A, 7A are views according to the arrows V′, VI and VII of FIGS. 5, 6, 7 respectively, wherein FIGS. 7-7A-8 illustrate an exemplary implantation sequence, and wherein FIG. 3A is an enlarged sectional view of details according to various embodiments and indicated by the arrows i), ii) and iii) in FIG. 3.

DETAILED DESCRIPTION

In the following description, numerous specific details are given to provide a thorough understanding of embodiments. The embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, etc. Reference throughout this specification to “one embodiment,” “an embodiment,” “exemplary embodiment,” or “various embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the use of these phrases throughout this specification is not necessarily intended to refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

With reference to FIGS. 1 and 2, reference 1 designates as a whole a kit for the implantation of a prosthetic vascular conduit according to various embodiments. In various embodiments, the kit may include a delivery tool or holder device 2 including a shaft 4 having a distal portion 6 and a proximal portion 8, wherein the shaft includes a handle 10 provided at the distal portion and a hub 12 coupled at an end of the proximal portion 8. In this description the terms “proximal” and “distal” are used with reference to the implantation site. By way of example, portions of the holder device 2 intended to operate in the proximity of the heart or at an implantation site will be referred to as “proximal,” while portions intended to operate away from the heart, for instance the handle 4 which may be in the hand(s) of a practitioner, will be referred to as “distal.”

In various embodiments, as shown for example in FIG. 2, the kit 1 may be used in conjunction with a base member 14 including a slot 16 configured for receiving the distal portion of the holder device 2. In particular, in various embodiments (and furthermore with the support of FIG. 3), the shaft 4 may be provided, at one end of the distal portion, with a pair of radially protruding tabs 18. In various exemplary embodiments, the tabs 18 are spaced by about 180 degrees.

The slot 16 may have a sufficient length and width in order for the tabs 18 to pass through, so that the shaft 4 can be rigidly coupled with the base member 14 by rotating the former after inserting the tabs 18 in the slot 16, thereby sliding the tabs 18 into corresponding bayonet fittings 20, which may be integral with the base member 14 (see, for example, FIG. 3). Several connecting means other than the bayonet coupling herein described may be used for coupling the shaft to the base member, e.g. releasable snap fittings. Coupling the shaft 4 to the base member 14 may render the holder device 2 self standing, as further described below.

In various embodiments, the hub 12 may be designed for receiving a prosthetic valve. In various embodiments, as shown for example in FIG. 2, the hub 12 may be substantially cup shaped and include:

- a first end portion with a coupling collar 22 adapted to be fitted at the end of the proximal portion 8,
- a cylindrical portion 24 having three windows 26 (which may e.g. be spaced 120 degrees apart), and
- a second end portion having a receiving member, e.g. a receiving collar 28, configured for serving as a temporary valve housing.

In various embodiments, at an intermediate position (e.g. substantially halfway along the shaft 4) a ring member 30 may be provided rigidly connected to the shaft 4 and which, in various embodiments, may exhibit radial protrusions 32, for example in the form of fingers or tabs. In various embodiments the protrusions 32 may be provided in the number of two (spaced 180 degrees) or three (spaced 120 degrees).

In various embodiments, a bushing 33 may be fitted onto the shaft 4 at a position between the ring member 30 and the hub 12. The bushing 33 may be slidable along the shaft 4 and in various embodiments may be provided with a flange 330.

In various embodiments, the components of the holder device 2 may be mounted coaxially to a longitudinal axis X1 of the holder device 2, As will be apparent from the following description, in various embodiments this may coincide with a longitudinal axis of a prosthetic vascular conduit coupled to the holder device 2.

In the figures, reference 40 denotes, as a whole, a prosthetic vascular conduit intended to be coupled with a prosthetic heart valve V to produce a so-called valved conduit or valve graft. Such a valved conduit may be used for replacing a native heart valve and an associated blood vessel in a patient. The aortic valve and the ascending aorta are one non-limiting examples of such a valve and an associated blood vessel. The pulmonary valve and the pulmonary artery may be other examples.

The valve V may be any type of valve adapted for replacement of a native heart valve in a patient. In various embodiments, the valve V may be a mechanical prosthetic heart valve. In various embodiments, such as those shown herein, the valve V may be a biological heart valve. Biological valves can be produced from animal tissues (e.g., bovine or porcine pericardium) cut, shaped and assembled (e.g., by stitching) to produce the desired valve structure. Valves for replacing a native heart valve can also be native valves derived from animals and treated to avoid degradation and adverse effects when implanted into the human body. So-called “porcine” valves obtained from native valves explanted from pigs are exemplary of this type of valves.

In various embodiments, the valve V may include a rigid or semi-rigid stent or be a so-called “stentless” type. An exemplary valve suited for use in the arrangement described herein may be a valve as disclosed in U.S. Pat. No. 5,713,953, including a base annular structure including a sewing ring 14, similar to the annulus of the native valve being replaced. In various embodiments (see e.g. FIG. 4), the sewing ring SR may exhibit a(n) (outwardly) flared shape.

In the exemplary embodiments shown, the valve V is associated with the conduit 40 in such a way that the valve leaflets (schematically indicated as VL) may control flow of blood through the conduit by permitting blood flow into the conduit 40 (i.e., blood flow into the aorta, when the conduit 40 is used for aortic replacement) while preventing (or restricting) flow of blood out of the conduit in the opposite direction (i.e., back into the left ventricle of the patient when used for aortic replacement). A reverse arrangement or orientation of the valve V is also possible.

As shown for example in FIGS. 1 and 2, the conduit 40 may include a terminal collar member 42 configured for receiving the annular portion, particularly the sewing ring SR, of the valve V. the collar member 42 includes a cuff 420 located at an end portion thereof and of the conduit 40, the cuff 420 being configured for the coupling of the valve V to the conduit 40.

In various embodiments, the sewing ring SR of the valve V may include a biocompatible textile material (e.g., PET such as Dacron®) and/or animal tissue (e.g., bovine or porcine pericardium) treated to be biocompatible. In various exemplary embodiments, the valve V is anchored to the conduit 40 by stitching (i.e., suturing) performed by a practitioner by taking advantage of both the sewing ring SR of the valve V and the cuff 420 being adapted to be traversed by a suturing material to produce suturing stitches.

In other exemplary embodiments, the conduit 40 includes a tubular textile structure. In various embodiments, the conduit 40 may have a length ranging from 2 centimeters to 10-12 centimeters, with a body portion 44 including a tubular wall of a textile material, such as PET (Dacron®). In various embodiments, the body portion 44 is in the form of a corrugated (i.e., crimped or grooved) structure providing longitudinal flexibility and radial compressibility, while ensuring that the conduit will not unduly radially expand under the pressure of blood flowing therethrough. In various embodiments, the body portion 44 may include a collagen-impregnated woven Dacron® graft. According to other embodiments, the body portion 44 is made from other structures well known in the area of vascular grafts.

In various embodiments used for replacing the ascending aorta, the conduit 40 may also include an intermediate portion 46 located between the body portion 44 and the terminal collar member 42. The intermediate portion 46 may include a material adapted to permit a radial expansion of the conduit wall into the Valsalva sinuses located immediately downstream of the aortic valve. Such a radial resiliency may be due to the intermediate portion 46 being made of a textile material having a stitching pattern such as to bestow on the resulting fabric a certain degree of resiliency. In various embodiments, the intermediate portion 46 may be pre-formed or fabricated to have a size and shape adapted to substantially mimic or replicate the shape of the native Valsalva sinus.

In various embodiments, one or both of the body portion 44 and the intermediate portion 46 of the conduit may be punctured or cut to open passages therein for connection of the coronary ostia.

In various embodiments, the cuff 420 (and the terminal collar member as well) may also similarly exhibit a certain degree of radial resiliency (i.e., expandability), possibly starting from an initial rest (i.e., unbiased or not expanded) condition where the terminal collar member 42 may have, at least marginally, a smaller diameter than the rest of the conduit 40. The terminal collar member 42 may include a textile material (e.g., knitted Dacron® thread) connected to the intermediate portion 46 to produce a radially expandable terminal portion of the conduit 40.

In various embodiments, the terminal collar member 42 may be a separate element (e.g., formed from a separate piece of material) from the body portion 44 and/or the intermediate portion 46. Connection of the terminal collar member 42 to the intermediate portion 46, as well as connection of the intermediate portion 46 to the body portion 44 or connection of the terminal collar member 42 to the body portion 44 (in embodiments not including the intermediate portion 46) may be achieved by any method or technique known in the art. In various exemplary embodiments, connection may be by one or more of knitting, stitching, or gluing.

In various embodiments, the body portion 44, the intermediate portion 46 and the terminal collar member 42 may be a single piece of material. For example, different sections of a same body including different knitting or stitching patterns. In various embodiments, the intermediate portion 46 can be dispensed with, whereby the terminal collar member 42 is directly connected to the body portion 44 by any of the techniques considered.

The terminal collar member 42 may be intended to accommodate the valve V to permit easy, fast and reliable coupling and subsequent anchoring of the valve V to the conduit 40. In exemplary embodiments, the cuff 420 may be intended to accommodate the annular portion of the valve V, namely the sewing ring SR.

In various embodiments, the terminal collar member 42, in particular the cuff 420, may be radially contractible (i.e., shrinkable). Radial contraction of the terminal collar member 42 may be due to inherent contractibility and/or be achieved via a positive contracting action. Elastic contractibility is exemplary of inherent contractibility. Elastic contractibility of the cuff 420 may be achieved via an elastically contractible member such as an elastic ring of a plastics material, a metallic ring (e.g., superelastic metallic alloys such as Nitinol), or an open, radially contractible ring of a rigid or semi-rigid material such as a metal or plastics material.

Radial contraction achieved via a positive contracting action may include shape memory (e.g., of a metallic member) or loop or a slip-knot (to be actuated by the practitioner) formed of a wire-like element such as suturing wire or a thread as used for manufacturing the conduit 40. In an exemplary embodiment as shown in the Figures, the cuff 420 may be made radially contractible by means of a purse-string design, i.e. a drawstring 421 passes through the cuff 420 in and out along a marginal edge thereof, so that upon pulling the drawstring 421 the diameter of the cuff 420 is reduced.

With reference to FIGS. 1 and 3, in various embodiments of the kit 1 the prosthetic vascular conduit 40 may be pre-mounted on the holder device 2 coaxially to the axis X1 and anchored thereto and to a sleeve member 48, as further described below. The sleeve member 48 may include either a flange or a pair of protruding tabs 480 and a tapered end portion 481.

FIG. 1 in particular shows an example of the kit 1 in an assembled configuration, ready for packaging (or for use in the operational theatre). More in detail, the conduit 40 may be fitted onto the holder device 2 so that the body portion 44 substantially surrounds the portion of the shaft 4 included between the ring member 30 and the hub 12 (or even a portion of the hub 12), while on the opposite end, at least a portion of the conduit adjacent to the cuff 420 may wrap around (or encircle) the receiving collar 28. Depending on the actual size and shape of the conduit and the hub 12, the receiving collar 28 may be wrapped (or encircled) by a portion of the conduit located across the interface between the intermediate portion 46 and the collar member 42 or, if the former is not present, between the body portion 44 and the collar member 42.

The sleeve member 48 may be fitted onto the conduit 40 in a position corresponding to the receiving collar 28 of the hub 12. The inner diameter of the sleeve member 48 may be sized and dimensioned to accommodate the conduit 40 and the receiving collar 28. Therefore, in various embodiments the inner diameter of the sleeve member 48 may exceed the external diameter of the receiving collar 28 by substantially twice the wall thickness of the conduit 40. In other embodiments the size of the inner diameter of the sleeve member may be different, in particular smaller, depending on the amount of radial contraction which is tolerated for the conduit 40.

A portion of the terminal collar member 42 adjacent to the cuff 420 and at least a stretch of the intermediate portion 46 (or the body portion 44, in case the intermediate portion 46 is not present) may thus be constrained between the sleeve member 48 and the receiving collar 28, as shown by way of example in FIG. 3.

Furthermore, the cuff 420 may be wrapped (or folded) over some or all of the outer surface of the sleeve member 48. In various embodiments the cuff 420 extends (or wraps) over at least the tapered end portion 481 of the sleeve member 48. Such arrangement can be obtained by up-turning the marginal edge of the cuff 420 on the sleeve member 48. In various embodiments, a first set of anchoring threads 50 may be passed through the cuff 420 and anchored on the sleeve member 48, particularly on the tabs 480 which may be provided with holes or grooves for receiving the threads 50. In exemplary embodiments, the set 50 includes two pairs of anchoring threads (or two single anchoring threads) spaced 180 degrees.

In various embodiments, with reference to FIG. 3A, a second set of anchoring threads 500 may be used to anchor the conduit 40 to the holder device 2. More particularly, in various embodiments a first end of an anchoring thread 500 may be connected (e.g. tied or otherwise fastened) to the flange 330 of the bushing 33. The anchoring thread 500 may then be routed—within the conduit 40—towards the hub 12 whereon a corresponding axial groove 120 may be provided. The thread 500 may thus traverse the groove 120 until it emerges from the interior of the conduit 40 and may be bent in a loop which is external with respect to the conduit and may be made to traverse the conduit 40 (e.g. in a position corresponding to the collar member 42), thereby returning inside the conduit itself.

With reference again to FIG. 3A, in one embodiment the hub 12 may be provided with radially protruding formations 121 which may offer an axial abutment surface to a locking ring LR provided within the body portion 44 (the intermediate portion 46 if present) at a position corresponding to the collar member 42. In various embodiments the locking ring LR may be an elastic ring having an undeformed diameter which is less than the outermost diameter of the hub 12 defined by the formations 121. The anchoring thread 500 may thus be bent in a loop around the locking ring LR, which in turn may bear upon the radially protruding formation 121.

The thread 500 may then be routed again along the groove 120 and towards the ring member 30, whereon a second end of the thread 500 is secured (e.g. tied or otherwise fastened), for instance to the tabs 32. The location of the ring member 30 along the shaft 4 may therefore be mainly dictated by the actual length of the conduit 40.

In various embodiments, the collar member 42 may be provided as a separate piece and may be stitched, for instance by means of stitches ST, to a free proximal end of the body portion 44 (the intermediate portion 46 if present), which in turn may be wrapped around the lock ring LR (thereby defining an annular pocket). In various embodiments the collar member 42 may itself be folded to form a pocket for the drawstring 421. In one embodiment, the stitches ST may traverse both the collar member 42 and the proximal end of the body portion 44 (the intermediate portion 46 if present), thereby securing the former and the latter together to form the conduit 40.

In various embodiments, the bushing 33 is slidable along the shaft 4 and the second end of each thread 500 may be drawn distally before being anchored to the ring member 30, so that the bushing 33 is made to slide along the shaft 4. In order to ensure a proper tensioning of the threads 500, the latter may be secured to the ring member 30 when the bushing 33 has come into contact with the hub 12 (see FIG. 3, for example).

In other embodiments the bushing may be fixedly coupled with the shaft 4, so that no sliding thereof will occur in when the second ends of the threads 500 are drawn prior to anchoring to the ring member 30.

In various embodiments, the threads 500 may includes two anchoring threads spaced (e.g., 180 degrees) apart or three anchoring threads spaced (e.g., 120 degrees) apart. The number of the grooves 120 may thus vary accordingly, preferably envisaging one groove 120 for each set of threads 500.

FIGS. 3 to 6 illustrate an exemplary sequence of coupling and anchoring the valve V to the conduit 40 pre-mounted on the holder device 2. In various embodiments (e.g. with reference to FIGS. 7-8) the holder device 2 may serve as a delivery tool for the prosthetic vascular conduit 40.

With reference to FIGS. 3 and 4, an operator, assisting the practitioner performing the implantation of a valved conduit in a patient, may couple the holder 2 to the base member 14 as previously described and arrange the assembly on a flat surface. The base member 14, as described, will render the holder 2 with the attached conduit 40 self-standing, so that it will stand in a substantially vertical position. In various embodiments, the base member may be provided as a separate item (i.e. in a different package), because it is made as a standard component, while the holder 2—in particular the receiving collar 28 and the whole hub 12—and the conduit 40 may be manufactured according to the specific sizes required by the patient. In other words, the receiving collar and the prosthetic valve intended to be received therein and coupled to the conduit 40 may have a diameter which is adapted to or optimized for the patient's anatomy.

In various embodiments, the prosthetic heart valve V, exemplified in the figures as a biological valve, may be preferably rinsed in a physiological solution before being coupled to the conduit. The valve V may then be inserted into the receiving collar 28 as shown in FIG. 4, so that the valve leaflets VL will face the interior of the hub 12 with the sewing ring SR contacting the marginal edge of the receiving collar 28.

In various embodiments, the sewing ring SR of the prosthetic valve V may be flared and/or have a maximum diameter which is slightly larger than the inner diameter of the receiving collar 28, so that the sewing ring abuts against the receiving collar 28 preventing the valve V from being pushed far too deep within the hub 12.

During this step, the hub 12 may serve both as a receiving means and a centering means for the valve V. Angular markers 410 (e.g., in the form of lines of contrasting color) can be provided in the wall of the conduit 40 to act as angular references in orienting the valve V with respect to the conduit 10. In addition or alternatively thereto, angular markers 422 (FIG. 1) can be provided in the cuff 42 to act as angular references in orienting the valve V with respect to the cuff 42.

The operator may then cut the anchoring threads 50, thereby removing the constraint which secures the cuff 42 to the sleeve member 48. In embodiments where the cuff 420 is provided with a certain degree of resiliency, the threads 50 may be tensioned to the extent that they slightly stretch the cuff, so that, with the threads cut, the cuff may return to an undeformed condition away from the cutting tool sharp edges, thereby minimizing the risks of accidental damage to the cuff.

With reference to FIG. 5, the operator may now be able to proceed and slide the sleeve member 48 (axially with reference to the axis X1) away from the hub 12 and the conduit 40, thereby unwrapping (or unfolding) the cuff 420, previously wrapped (or folded) thereon, such that is wraps around (or encircles) the annular portion—and in particular the sewing ring SR—of the valve V. FIGS. 5 and 5A provide a schematic view of a possible configuration of the unwrapped (or unfolded) cuff 420. The sewing ring SR is then laterally surrounded by the cuff 420, with a proximal edge of the cuff 420 extending slightly above a proximal surface of the sewing ring SR.

A next step is depicted in FIGS. 6 and 6A. In various embodiments, the purse string design of the cuff 420 may permit an easy and rapid coupling of the valve V to the conduit 40. By pulling the drawstring 421 in a direction P (in this example away from the axis X1), the operator may cause a radial contraction (shrinking) of the cuff 420, thereby wrapping (or securing) the latter around the sewing ring SR. The coupling of the valve V to the conduit 40 may thus be completed. FIG. 6A depicts a schematic view, seen from the top of the holder device 2, which shows an exemplary configuration of the conduit 40 when the coupling with the valve V is completed, with the sewing ring SR substantially entirely wrapped within the cuff 420.

In various embodiments, the cuff 420 may be sized and dimensioned to radially cover only the sewing ring SR without interfering with the orifice defined in the valve V for the passage of blood.

The implantation site may then be prepared for the implantation of the valved conduit. FIG. 7 shows a schematic view of a human heart H during the implantation of the valved conduit. The main blood vessels are labeled for prompt reference (the direction of blood flow is also shown). Such vessels include the aorta AO, the pulmonary veins PV, the pulmonary artery PA, the inferior vena cava IVC and the superior vena cava SVC. The natural heart valves schematically depicted in FIG. 7 include the pulmonary valve PV, the tricuspid valve TCV and the mitral valve MV. The aortic valve is not represented herein because in the example shown in FIG. 7 the valved conduit is intended for the implantation at the aortic annulus, wherein the valve V will replace the native aortic valve. The right atrium and the left atrium are indicated by RA and LA respectively, while the right ventricle and the left ventricle are indicated by RV and LV, respectively.

In various embodiments, suture threads S may be first passed through the aortic annulus at a number of positions therealong. The operator meanwhile may release the holder 2 from the base member 14 and pass it to the practitioner, who, in turn, may pass suture threads S through the cuff 42, the sewing ring SR and the cuff 42 again (see for reference FIG. 7A). The flared geometry of the sewing ring SR provided in various embodiments may offer an area to be pierced by suturing needles while passing the threads, while the hub 12 helps in preventing damages to the valve leaflets VL.

The practitioner may then “parachute” the valved conduit, still coupled to the holder device 2, along the threads S and reaches the implantation site (i.e. the aortic annulus). FIG. 7A shows how the stitching procedure creates a compressed pack of fabric layers aimed at achieving an effective fixation and minimizing leakage.

The valved conduit may then be secured to the implantation site by tying the suture threads S while it is still coupled to the holder device 2.

With reference to FIG. 8, the operator may complete the implantation of the valved conduit by cutting the threads 500 that secure the conduit 40 to the holder device 2. The holder device 2 may then be retracted (i.e., moved away) from the conduit 40 and the valve V, which remains firmly anchored to the implantation site.

For those embodiments where the threads 500 follow the path (or a similar configuration) shown in FIG. 3A, where the threads 500 extend between the flange 330 of the bushing 30 and the ring member 33, a portion of the threads 500 extending distally from the vascular conduit 40 are exposed. This exposed portion of the threads 500 may provide a convenient location at which the practitioner may cut the threads 500. Further, in such embodiments, as the threads 500 remain attached at one end to the bushing 30 and at another end to the ring member 33, upon removal of the holder device 2 from the conduit 40, all portions of the threads 500 will also be carried away from the implantation site.

Without prejudice to the underlying principles of the invention, the details and embodiments may vary, even significantly, with respect to what has been described herein, merely by way of example, without departing from the scope of the invention as defined by the annexed claims. Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the above described features.

The sewing ring SR of the valve V may have, in other embodiments, a shape which resembles that of a torus. In such embodiments, the outermost diameter (larger than an inner diameter of the receiving portion) of the torus shaped sewing ring may contact the inner side of the receiving portion 28 when the valve V is inserted within the hub 12 and the advancement of the valve V within the hub 12 may be stopped when such outermost diameter contacts and engages the receiving portion, for instance by interference therewith.

Additionally, preferred embodiments of the invention are included in the following examples.

Embodiment 1: a kit for the implantation of a prosthetic vascular conduit including:

- a prosthetic vascular conduit for coupling to a prosthetic valve having an annular portion, the prosthetic vascular conduit including a terminal collar member to receive the annular portion of the valve, wherein the terminal collar member includes a cuff which is radially contractible to engage the annular portion of the valve to couple the valve to the conduit,
- a holder device including a shaft and a hub located at an end of a proximal portion of the shaft, the hub including a receiving portion to house a prosthetic valve, wherein the prosthetic vascular conduit is fitted on the holder device so that at least a portion of the conduit adjacent to the cuff folds the receiving portion of the hub,
- a sleeve member fitted onto the conduit at a position corresponding to the receiving portion of the hub, wherein the cuff is wrapped on the sleeve member, and
- wherein the sleeve member is slidable away from the hub to unwrap the cuff the annular portion (SR) of a prosthetic valve housed within the receiving portion of the hub.

Embodiment 2: the kit of embodiment 1, wherein the cuff is located at an end portion of the collar member.

Embodiment 3: the kit of

embodiment

1 or 2, wherein the cuff has a purse-string design including a drawstring passing through the cuff in and out along a marginal edge thereof.

Embodiment 4: the kit of any of the previous embodiments, wherein the terminal collar member of the conduit is anchored to the sleeve member by means of a first set of anchoring threads.

Embodiment 5: the kit of embodiment 4, wherein the first set of anchoring threads is passed through the cuff, wherein the sleeve member can be slid away from the conduit once the anchoring threads of the first set are defeated.

Embodiment 6: The kit of any of the previous claims, wherein the conduit is anchored to the holder device by means of a second set of anchoring threads.

Embodiment 7: the kit of embodiment 5, further including a ring member rigidly connected to the shaft, the anchoring threads of the second set being secured to the ring member.

Embodiment 8: the kit of any of the previous embodiments, wherein the shaft includes a handle provided at a distal portion thereof.

Embodiment 9: the kit of any of the previous embodiments, wherein at an end of the distal portion there are provided coupling means for coupling the holder device to a base member.

Embodiment 10. the kit (1) of any of the previous embodiments, wherein the cuff is formed of a material permitting suturing of the annular portion of a prosthetic heart valve to the conduit.

Embodiment 11: the kit of embodiment 10, wherein the annular portion is a sewing ring of the prosthetic heart valve.

Embodiment 12. the kit of any of the previous embodiments, wherein the cuff includes at least one angular marker for angularly referencing a prosthetic heart valve with respect to the cuff.

Embodiment 13: the kit of any of the previous embodiments, wherein the conduit includes a radially expandable portion adjacent the collar member.

Embodiment 14: a method of making a prosthetic valved conduit, the method including the steps of:

- providing a kit according to any of the previous embodiments;
- providing a prosthetic heart valve having an annular portion;
- advancing the heart valve prosthesis into the receiving portion of the hub until the annular portion of the prosthetic heart valve contacts the receiving portion;
- sliding the sleeve member away from the hub to unwrap the cuff of the prosthetic vascular conduit around the annular portion of the prosthetic heart valve, and
- wrapping the cuff of the prosthetic vascular conduit around the annular portion of the prosthetic heart valve by providing a radial contraction of the cuff.

Embodiment 15: the method of embodiment 14, wherein the cuff has a purse-string design including a drawstring passing through the cuff in and out along a marginal edge thereof, and wherein the. step of wrapping the cuff is performed by pulling the drawstring.

Claims

The invention claimed is:

1. A method of assembling a prosthetic valved conduit, comprising:

providing a kit including:

a prosthetic heart valve having an annular portion;

a prosthetic vascular conduit having a terminal collar member to receive the annular portion of the prosthetic heart valve, the terminal collar member including a cuff that is radially contractible to engage the annular portion of the prosthetic heart valve to couple the prosthetic heart valve to the prosthetic vascular conduit;

a holder device including a shaft and a hub located at an end of a proximal portion of the shaft, the hub including a receiving portion to house the prosthetic heart valve, wherein the prosthetic vascular conduit is fitted on the holder device so that at least a portion of the conduit adjacent to the cuff wraps around the receiving portion of the hub; and

a sleeve member fitted onto the prosthetic vascular conduit at a position corresponding to the receiving portion of the hub, wherein the cuff is wrapped at least partially over the sleeve member;

advancing the prosthetic heart valve into the receiving portion of the hub until the annular portion of the prosthetic heart valve contacts the receiving portion;

sliding the sleeve member away from the hub to cause the cuff of the prosthetic vascular conduit to wrap around the annular portion of the prosthetic heart valve; and

securing the cuff of the prosthetic vascular conduit around the annular portion of the prosthetic heart valve by radially contracting the cuff.

2. The method of claim 1, wherein the cuff has a purse-string design including a drawstring passing through the cuff in and out along a marginal edge thereof, and wrapping the cuff comprises pulling the drawstring.

3. The method of claim 1, further comprising anchoring the terminal collar member of the prosthetic vascular conduit to the sleeve member by passing a first set of anchoring threads through the cuff.

4. The method of claim 1, further comprising anchoring the prosthetic vascular conduit to the holder device via a second set of anchoring threads.

5. The method of claim 1, further comprising coupling the holder device to a base member to hold the holder device in a vertical orientation.

6. The method of claim 1, further comprising subsequently implanting the prosthetic valved conduit.

7. The method of claim 6, wherein implanting the prosthetic valved conduit comprises:

placing suture threads through an aortic annulus;

passing the suture threads through the cuff, a sewing ring and again through the cuff;

parachuting the prosthetic valved conduit along the suture threads to the aortic annulus;

securing the prosthetic valved conduit to the aortic annulus by tying the suture threads;

cutting the suture threads securing the prosthetic vascular conduit to the holder device; and

removing the holder device.

8. A method of assembling a prosthetic valved conduit, comprising:

providing a kit including:

a prosthetic heart valve having an annular portion;

a holder device including a shaft and a hub located at an end of a proximal portion of the shaft, the hub including a receiving portion including an inner portion to house a prosthetic heart valve and an outer portion, wherein the prosthetic vascular conduit is fitted on the holder device so that at least a portion of the prosthetic vascular conduit adjacent to the cuff surrounds the receiving portion of the hub and contacts the outer portion of the receiving portion; and

a sleeve member fitted onto and surrounding the prosthetic vascular conduit at a position corresponding to the receiving portion of the hub, wherein an inner surface of the sleeve member contacts the prosthetic vascular conduit and the cuff is wrapped at least partially over and around the sleeve member such that the cuff contacts an outer surface of the sleeve member;

removing the sleeve member from the hub to cause the cuff of the prosthetic vascular conduit to lose contact with the inner and outer surfaces of the sleeve member and be wrapped around the annular portion of the prosthetic heart valve; and

9. The method of claim 8, wherein the cuff has a purse-string design including a drawstring passing through the cuff in and out along a marginal edge thereof, and wrapping the cuff comprises pulling the drawstring.

10. The method of claim 8, further comprising anchoring the terminal collar member of the prosthetic vascular conduit to the sleeve member by passing a first set of anchoring threads through the cuff.

11. The method of claim 8, further comprising anchoring the prosthetic vascular conduit to the holder device via a second set of anchoring threads.

12. The method of claim 8, further comprising coupling the holder device to a base member to hold the holder device in a vertical orientation.

13. The method of claim 8, further comprising subsequently implanting the prosthetic valved conduit.

14. The method of claim 13, wherein implanting the prosthetic valved conduit comprises:

placing suture threads through an aortic annulus;

cutting the suture threads securing the prosthetic vascular conduit to the holder device; and removing the holder device.